An Observational Follow-Up Study of Pediatric Patients Who Participated in a Previous Respiratory Syncytial Virus (RSV)-Induced Bronchiolitis Study of Montelukast
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 主要终点
- Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
研究概览
简要总结
This is a prospective, multicenter, observational study in participants who completed the 24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the treatment of respiratory symptoms subsequent to RSV-induced bronchiolitis. The purpose of this study is to better understand the clinical and demographic correlates of asthma and atopic disorders in children (through the age of 6 years) with a history of severe RSV-induced bronchiolitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •successfully completed MK-0476 Protocol 272
- •had RSV-induced bronchiolitis at entry into Protocol 272
排除标准
- •had developed or had been diagnosed with any illness or congenital disorder that could be immediately life threatening
结局指标
主要结局
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
时间窗: At 6 years of age
Asthma was defined as a positive response to the Epidemiology Questionnaire item "Has your child had wheezing or whistling in the chest in the past 6/12 months?" for the period of 12 months prior to age 6 years. Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.
次要结局
- Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor(At 6 years of age)
- Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor(At 6 years of age)